Fair Balance & Web Link Destination Examples (HCP advertising)

Transcription

1 Fair Balance & Web Link Destination Examples (HCP advertising) July 2013

2 Guidance Document Content Flow Purpose The old Figure 1: Journal Ad Figure 2: Product summary The new Figure 3: Highest level fair balance for Toviaz Figure 4: Web link destination Figure 5: Web link destination containing references & study parameters Using middle level to lead to highest level fair balance Figure 6: Example Journal ad for Toviaz Figure 7: Highest fair balance placed elsewhere Figure 8: Highest fair balance placed elsewhere with references and parameters Or key uses for middle level leading to highest level fair balance Figure 9: Slide out ruler Figure 10: Sample holder Purpose This document is essentially a collection of examples. Its purpose is to crystalize principles in PAAB codes 4.4 & 7.3 and concepts discussed in PAAB guidance documents Guidance on generating three base fair balance levels (HCP advertising) and Guidance on base fair balance level selection and placement in Healthcare Professional APS. It is strongly recommended that you read those documents prior to reading present document. The Old Figure 1 shows 2012 Toviaz journal ad while Figure 2 shows PI that this ad refers to.

3 Figure 1: Layout for 2012 Toviaz journal ad (i.e. before code change). [Ty pe a quo te fro m doc um ent or sum mar y of an inte resti ng poin t. You can posi tion text box any whe re in doc um ent. Use Dra win g Too ls tab to cha nge for mat ting of pull 76

4 The fair balance is in bottom left quadrant. Additionally, icon in extreme bottom right corner directs reader to go to page 76 within publication for prescribing summary. Figure 2 is prescribing summary spanning over 2 pages. This is what reader would see upon arrival to page 76. Figure 2: Toviaz 2012 Prescribing Summary (2 pages)

5 The New Figure 3 is one of ways Toviaz ad can look after July 2013 PAAB code change. The highest level of base fair balance is employed because APS contains rapeutic claims.

6 Figure 3: Toviaz highest level fair balance [Ty pe a quo te fro m doc um ent or sum mar y of an inte resti ng poin t. You can posi tion text box any whe re in doc um ent. Use Dra win g Too ls tab to cha nge for mat ting of pull

7 The web page at URL in Figure 3 fair balance is a hypotical page on HCP gated website Figure 4 shows an example of what this hypotical web page could look like (for training purposes only, this webpage does not exist and has not been approved by Pfizer). Note that Toviaz does not have a July 2012 Dear HCP letter. The corresponding icon has been added for demonstration purposes only. Figure 4: Hypotical web link destination for Toviaz Click here to visit Toviaz.ca homepage As per PAAB code section 7.3, this page must be accessible without need to enter a password. This is possible as APS containing URL is distributed or made viewable in controlled fashion (i.e. targeted for HCPs). The URL itself refore acts as key into Toviaz website. This is why you ll note URL is not simply There is no need for PAAB review of this web page provided content is limited to that listed in PAAB code section 7.3.2b. The references and study parameters are reviewed within context of corresponding APS. The reference list and study parameters may appear in APS as in Figure 3. However, y could have alternatively been moved to web link destination as shown in Figure 5. The click through to TMA (and Dear HCP letter if applicable) must be very prominent on web link destination (e.g. large and first item on page). Please note that study parameters and reference list may appear eir on face of weblink destination (as in Figure 5) or y may be relegated to a click through button.

8 Figure 5: Hypotical web link destination for Toviaz (with references & study parameters) It is important to note that study parameters are only footnotes which can be relegated to web link destination. Disclaimers and definitions, for example, must remain on face of ad (on same surface as claims y are qualifying) in order to satisfy PAAB code section 2.1. Rar than Toviaz website, manufacturer could have used a URL leading directly to product monograph PDF document stored on corporate website or to Drug Product Directory search page on Health Canada website. This would impose some limitations on manufacturer options vis-à-vis reference list and study parameters. Using middle level to lead to highest level fair balance The APS in figure 3 employs highest level fair balance as it has rapeutic claims. However, manufacturer could instead choose to use middle fair balance on face of APS to direct reader elsewhere to a surface which is easily accessible (e.g. same media) and conducive to easy reading. In Figure 6, we ve modified Figure 3 APS to accomplish this.

9 Figure 6: Middle level used to direct reader to highest level fair balance [Ty pe a qu ote fro m do cu me nt or su m ma ry of an int er est ing poi nt. Yo u ca n po siti on tex t bo x an yw he re in do cu me nt. Us e Dr aw ing To

10 When reader goes to page XX, y ll see Figure 7. In this case, would be figure 5. Note that relevant page XX presentation should begin with product logo so as to be easily located (and differentiated from or content on page). As Toviaz does not have any emphasized warnings and precautions (e.g. bolded/boxed) or a long list of clinical use issues in Indication and Clinical Use section of product monograph, benefits of using middle fair balance within main advertising message to direct HCPs to highest level elsewhere are not as pronounced as y would be for or products. Figure 7: Highest fair balance placed elsewhere This brings us to anor potential location for references and study parameters. In Figure 8, we ve added references and study parameters to surface containing highest level fair balance (rar than keeping m on ad or moving m to web-link destination). In this case, would be figure 4. Figure 9 shows minimum font sizes for content which does not appear on face of ad. These minimum requirements apply wher content appears on web link destination or elsewhere such as some or page within publication. There are no minimum fair balance font sizes for content on face of ad (as fair balance size on face of ad should be comparable to benefit copy font size).

11 Figure 8: Highest fair balance placed elsewhere with references and parameters Figure 9: Font sizes for content which is not located on face of ad

12 Or key uses for middle level leading to highest level fair balance For a slide ruler (see figure 10) main advertising area is generally confined to external outer facing surfaces (front & back). The ruler itself, which slides out, is not considered part of main advertising surface. The manufacturer has option of placing middle level fair balance on exterior directing reader to remove ruler in order to access highest level fair balance. It is possible that ruler even unfolds thus offering a larger surface area. The reader n folds ruler and easily slides it back into outer case for continued use of tool. Or tools like bellybands, shelf talkers and tent cards offer similar opportunities. Figure 10: Slide ruler The main advertising area on a sample holder (see figure 11) is generally confined to frontfacing and side-facing panels. The back panel is typically pushed up against back of cupboard wall. Middle level fair balance can be used on front or side panels to direct HCP to pull holder out of cupboard so as to view back panel for highest level fair balance. Note that highest level fair balance may not appear on inside panels or bottom panel as reading content on se surfaces would require awkward positioning or emptying of sample tray. For similar reasons, highest level of fair balance could not appear on top or bottom shelf talker surfaces which rest on shelf (i.e. product would need to be removed to make balance copy visible).

13 Figure 11: Sample holder Electronic banner ads in HCP gated environments which contain product claims require fair balance. Relegating fair balance to a click through would not meet this requirement as this would constitute separation of claims from fair balance. However, middle fair balance may appear on face of banner with a click through directly to highest fair balance. In such a case, highest fair balance should be presented on face of weblink destination (i.e. highest level fair balance should not be relegated to a button found on weblink destination requiring additional click through). Although this disqualifies weblink destination from being exempt from preclearance, this option simplifies communication of rapeutic claims on banner ads. Note that where multiple frames are used in banner ad, indication should appear on (or prior to) first frame containing explicit marketing claims of benefit (refer to document Guidance on Indication Placement in Advertising ). Please refer to PAAB document Guidance on base fair balance level selection and placement for discussion on use of middle fair balance on homepage of product websites. The Web Link Destination The URL or electronic link can lead to any of destination pages listed in PAAB code section 7.3. Web link destinations on company/agent controlled product or corporate websites containing content which exceed elements listed in 7.3.2b require PAAB review as a separate APS. All visible content on such pages (including but not limited to links and/or menu items) would be reviewed in product branded context.